510(k) K110278 ยท EKX Handpiece, Direct Drive, Ac-Powered
CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900
| Applicant | Nakanishi, Inc., Richardson TX, US |
| Decision | Substantially Equivalent, Feb 15, 2012 |
| Received | Jan 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110278
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.